Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms
NCT ID: NCT05173818
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2022-06-28
2025-08-01
Brief Summary
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Examples of persistent post-concussion symptoms include balance problems, headaches, fatigue, poor concentration, forgetfulness, anxiety, irritability, and sleep disturbance. Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury.
The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms.
The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS.
Detailed Description
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This study is designed to determine whether hyperbaric oxygen improves neuropsychological status and ameliorates symptoms in adults with persistent post-concussive symptoms (PPCS) following mild traumatic brain injury. It recruits from either military or civilian population; uses a validated screening tool - Repeatable battery for the assessment of neuropsychological status (RBANS)- used in dementia and other forms of brain injury not used hitherto, in previous randomized control trial that investigated the effectiveness of hyperbaric oxygen in the management of PPCS. It also includes a concssuon biomarker, as an objective secondary endpoint.
The study is based on repeated measure design. The study will describe and track changes in the outcomes of interest over time, and examine associations between measures within each participant and across certain participant characteristics.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HBO at 1.5 Atmosphere absolute
Participants in this group will be exposed to hyperbaric oxygen at 1.5 atmosphere absolute (ATA) for 60 minutes per session. Each participant will complete 40 sessions, five sessions per week within 3 months from randomization
Hyperbaric oxygen at 1.5 ATA
Hyperbaric oxygen (HBO2) at 1.5 ATA (active) group (hyperbaric oxygen-chamber compressed to 1.5 atmosphere absolute and breathing \>99.9% oxygen). Each participant should complete 40 sessions, one session per day, five per week over the course of 3 months.
Sham control initially at 1.2 then changed to 1.0 ATA
Participants in this group will be exposed to hyperbaric oxygen at 1.2 atmosphere absolute (ATA) during the first 5 to 7 minutes and the chamber pressure will be reduced to 1.0 ATA for the remaining 53 - 57 minutes for a total of 60 minutes per session. Each participant will complete 40 sessions, five sessions per week within 3 months from randomization
Sham treatment
Sham treatment includes pressurizing the chamber to 1.2 ATA with air for 5 minutes with noise of circulating air, return the chamber to 1.0 ATA after 5-7 minutes and maintain it at that pressure for until the end of the treatment, with noise of circulating air. Internal control knobs will be concealed. Participants will be instructed to undergo intermittent ear clearing technique during the initial 5 minutes of "descent"
Interventions
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Hyperbaric oxygen at 1.5 ATA
Hyperbaric oxygen (HBO2) at 1.5 ATA (active) group (hyperbaric oxygen-chamber compressed to 1.5 atmosphere absolute and breathing \>99.9% oxygen). Each participant should complete 40 sessions, one session per day, five per week over the course of 3 months.
Sham treatment
Sham treatment includes pressurizing the chamber to 1.2 ATA with air for 5 minutes with noise of circulating air, return the chamber to 1.0 ATA after 5-7 minutes and maintain it at that pressure for until the end of the treatment, with noise of circulating air. Internal control knobs will be concealed. Participants will be instructed to undergo intermittent ear clearing technique during the initial 5 minutes of "descent"
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Volunteers time from concussive incident (Mild traumatic brain injury) must be between 3 months - 5 years following head trauma incident
* TBI was caused by non-penetrating trauma
* Volunteers must have current complaints of TBI symptoms such as headache, dizziness, or cognitive or affective problems
* Volunteers must be 18-year-old or more
* Willing and able to provide informed consent
* Able to speak and read English, as primary language
* Agrees to provide blood samples for clinical lab tests
* Willing and committed to comply with research protocol and complete all outcome measures
* Able to equalize middle ear pressures or willing to undergo needle myringotomies if needed
* Willingness and committed to comply with study protocol outlined reproductive plan based on baseline reproductive status
Exclusion Criteria
* Hyperbaric chamber inside attendant, professional, SCUBA diver (technical, commercial, operational/military or recreational)
* The investigators will exclude pregnant women from this study because potential fetal adverse reactions triggered by high oxygen partial pressures such as retrolenticular fibroplasia though careful review of human data are generally reassuring such as the use of hyperbaric oxygen to treat acute carbon monoxide poison in the pregnant patient.13
* Prisoners
* Minors
* Unable to protect airway or requires frequent suctioning
* Known or suspected peri-lymphatic fistula
* Presence of tracheostomy (due to limitations in auto-inflating the middle ear)
* Unable to participate fully in outcome assessments
* Unable to cooperate with hyperbaric oxygen treatments
* Unable to speak and read English, as primary language
* Not cooperating with instructions during hyperbaric oxygen treatments such as bringing contraband items into the chamber (such as fire lighter)
* Not competent to sign their own consent. Such potential participants will not have the capacity to participate in a full range of neurocognitive testing
* Pre-existing diagnosis of a psychotic disorder(s): schizophrenia, bipolar, dissociative disorder
* History of moderate or severe traumatic brain injury
* History of brain injury not of traumatic etiology such as stroke or drug-induced coma
* Verifiable diagnosis of learning disability. Other pre-existing cognitive issues may make it difficult for potential participants to fill out certain outcome assessments such as neurobehavioral symptomatic inventory. This could lead to measurement bias or confound the result.
* Claustrophobia and unwilling to enter hyperbaric chamber
* Untreated pneumothorax
* Presence of implanted device with un-verifiable test to pressure by manufacturer
* Concurrent enrollment in an alternate interventional trial for post concussive symptoms
18 Years
ALL
No
Sponsors
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University of North Dakota
OTHER
Dakota Medical Foundation
UNKNOWN
The Swanson Foundation
UNKNOWN
State of North Dakota
UNKNOWN
Essentia Health
OTHER
Responsible Party
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Principal Investigators
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Olayinka D Ajayi, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Essentia Health
Marc Basson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Dakota
Marilyn Klug, PhD
Role: STUDY_CHAIR
University of North Dakota
Paulina Kunecka, MD
Role: STUDY_CHAIR
Essentia Health
Richard Ferraro, PhD
Role: STUDY_CHAIR
University of North Dakota
Rebecca Quinn, MSW, LMSW
Role: STUDY_CHAIR
Center for Rural Health, University of North Dakota
Sharon Hanson, RN
Role: STUDY_DIRECTOR
Essentia Health
Locations
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Essentia Health
Fargo, North Dakota, United States
Countries
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References
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Moser RS, Schatz P. Enduring effects of concussion in youth athletes. Arch Clin Neuropsychol. 2002 Jan;17(1):91-100.
Shahim P, Politis A, van der Merwe A, Moore B, Chou YY, Pham DL, Butman JA, Diaz-Arrastia R, Gill JM, Brody DL, Zetterberg H, Blennow K, Chan L. Neurofilament light as a biomarker in traumatic brain injury. Neurology. 2020 Aug 11;95(6):e610-e622. doi: 10.1212/WNL.0000000000009983. Epub 2020 Jul 8.
Cook PA, Johnson TM, Martin SG, Gehrman PR, Bhatnagar S, Gee JC. A Retrospective Study of Predictors of Return to Duty versus Medical Retirement in an Active Duty Military Population with Blast-Related Mild Traumatic Brain Injury. J Neurotrauma. 2018 Apr 15;35(8):991-1002. doi: 10.1089/neu.2017.5141. Epub 2018 Mar 1.
Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price RC, Williams CS, Orrison WW, Walker JM, Meehan A, Mirow S. Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial. Undersea Hyperb Med. 2018 Mar-Apr;45(2):129-156.
Other Identifiers
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EH21714
Identifier Type: -
Identifier Source: org_study_id